Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery

  • STATUS
    Recruiting
  • End date
    Dec 2, 2023
  • participants needed
    40
  • sponsor
    Sonoran Spine Research and Education Foundation
Updated on 24 May 2022
morphine
postoperative pain
leg pain
Accepts healthy volunteers

Summary

This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.

Description

Background Deformity surgery is considered one of the most painful procedures patients can undergo in medicine today. Stringent protocols for pain management have done much to dramatically increase patient satisfaction, but the procedure still lags considerably behind advances in pain control when compared to other procedures such as total joint surgery. Specifically, it has been reported that over half of patients undergoing spine surgery report inadequate pain control the first 24 hours after surgery. Uncontrolled pain has been shown to correlate with prolonged hospital stays, delayed ambulation, poor functional outcomes, and increased risk for the development of chronic pain. Furthermore, the large amount of narcotics given to patients in an attempt to mitigate their pain postoperatively often leads to significant complications in their own right, such as ileus, mental status changes, and nausea. New modalities to treat postoperative pain, especially in the initial days following deformity correction, are needed.

Intrathecal (subarachnoid) injection of morphine has been used to treat severe pain since the 1970's. Its efficacy in treating postoperative pain has been well documented in various specialties including obstetrics, oncology, general surgery, and orthopedic surgery. Specific to spine surgery, intrathecal morphine is an attractive option given the access and visualization of the thecal sac in addition to the high demand of pain control required postoperatively. However, there remains no definitive consensus regarding the use of intrathecal morphine in spine surgery. Current literature is limited by few randomized trials, small sample sizes, heterogeneity of outcomes recorded, and an unclear association with complications. Additionally, there is a paucity of data dedicated to patients undergoing deformity correction. Accordingly, there is a need for high-quality trials to investigate the role of intrathecal morphine in adult spinal deformity surgery.

In this study, we hypothesized that the use of intrathecal morphine will significantly reduce post-operative pain after deformity surgery, reduce opioid utilization, decrease hospital stay, allow for earlier ambulation, increase patient satisfaction, and have comparable complications to traditional pain management strategies. This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.

Details
Condition Low Back Pain
Treatment Intrathecal Morphine injection, Pain Relieving
Clinical Study IdentifierNCT05092828
SponsorSonoran Spine Research and Education Foundation
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients 18 years and older with a diagnosis of adult or degenerative scoliosis
Patients meeting criteria for surgical correction involving back and/or leg pain
Fusion of 4+ levels
Competency to undergo informed consent process
Medical clearance for spinal fusion surgery

Exclusion Criteria

Patients with lumbar spine inaccessible for intrathecal Duragesic (fused L2-S1)
Patients undergoing 3 or less levels of fusion
Patients with neuromuscular disease
Opioid intolerance or dependence
Severe coexisting diseases
ASA III
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